BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2091827 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03502
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE OK AND DOWN KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    PATIENT'S MOTHER REPORTS THAT OK AND DOWN ARROW BUTTONS REQUIRES MULTIPLE PRESSES TO RESPOND. PATIENT'S MOTHER REPORTS NOTICED ISSUE A MONTH AGO AND HAS BEEN GETTING WORSE. ALL OTHER BUTTONS FEEL NORMAL AND RESPOND NORMALLY TO PRESSES. PATIENT DOES NOT CLEAN PUMP. PATIENT WEARS PUMP IN POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR